icf template - med.stanford.edu€¦ · 1 today, you are being asked to take part in this research...

Consent to Participate in a Research Study

Day and night closed-loop in young people with type 1 diabetes (DAN05)

DAN05 Adult Informed Consent v 2.0 Stanford 3-24-17 of 22

Today, you are being asked to take part in this research study because you have type 1 diabetes 1

and use an insulin pump. The goal of this research is to get new knowledge that may help other 2

people, but it is not the same as treatment of type 1 diabetes. We want to find what works best 3

for treating your and others with this condtion. 4

5

Your study team will be talking with you about this research and this document. Please take 6

your time deciding whether you want to participate in this research and please carefully read this 7

document. To take part in the study, you will need to carefully read and sign this document. 8

9

Before you decide to take part in this research study, we encourage you to speak with friends and 10

family members about it. If you do not understand all the information, please ask your study 11

doctor or nurse to explain. If you are taking part in another study, please tell us right away. 12

13

NON-PARTICIPATION STATEMENT 14 Participation in this study is voluntary and you must agree to take part. If you decide to stop 15

participation in this research, that will happen immediately. No penalty or loss of medical care 16

will result from your decision. While the study is occurring you may continue to receive medical 17

care not related to this study. 18

19

WHO IS DOING THE STUDY 20 Your study team will carry out this study. Their names are listed on the Cover Page of this form. 21

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) which is part of 22

the National Institutes of Health (NIH) is paying for this research. This funding will be used by 23

the Jaeb Center for Health Research to organize the study and pay your study doctor(s). 24

25

WHY ARE WE DOING THIS STUDY? 26 The purpose of this study is to compare an automated insulin management system (study system) 27

to using an insulin pump alone. The study system includes (1) a CGM that measures glucose 28

levels, (2) a computer program on a smartphone that determines how much insulin is needed, and 29

(3) an insulin pump that delivers the insulin. The name of this closed-loop system is FlorenceM. 30

Half of the people taking part in the study will use the study system. The other half will continue 31

to use their own insulin pump. 32

33

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34 The CGM sensor has a needle that is inserted just under the skin. It measures the glucose in the 35

fluid beneath the skin and shows this on the pump screen every 5 minutes. The sensor needs to 36

be changed about every 7 days. The insulin pump has a tube that is inserted under the skin. It 37

needs to be changed about every 3 days. This may be similar to the insulin pump infusion set you 38

are already using. 39

40

The CGM and insulin pump are made by Medtronic MiniMed, Inc. The pump model name is 41

the Medtronic 640G. The CGM sensor is called the Enlite 3 Sensor. It also is made by 42

Medtronic Minimed, Inc. 43

44

The Enlite 3 Sensor, the Medtronic 640G insulin pump, and the overall FlorenceM system used 45

in this study are experimental. This means they can only be used for research. Because of this, 46

we call the entire system an investigational device. The Food and Drug Administration (FDA) 47

and The Medicines and Healthcare Products Regulatory Agency (MHRA) have approved its use 48

in our research study. 49

50

We have tested an earlier version of the system in more than 170 people in both the hospital and 51

the home. We did not find any higher risk for high or low blood sugars or other problems. 52

53

HOW MANY PEOPLE ARE WE EXPECTING TAKE PART IN THIS STUDY? 54 We expect about 130 people will take part in this study at six centers in the United States and the 55

United Kingdom. 56

57

58

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WHO CAN PARTICIPATE IN THIS STUDY? 59 To take part in this study, you will need to: 60

1. Be at least 6 years old and no older than 18 years old 61

2. Have type 1 diabetes for at least one year 62

3. Have an HbA1c of at least 7.5% and no higher than10.0% (HbA1c is a measure of your 63

blood sugar control) 64

4. Be using an insulin pump for at least the last three months 65

5. Have access to Wi-Fi in your home and a computer for uploading device data and doing 66

online questionnaires 67

6. Live with a family member/guardian who is willing to be trained on use of the system 68

7. Avoid taking acetaminophen (Tylenol) during the study 69

8. Speak and understand English 70

9. Have a negative pregnancy test if you are a female who could become pregnant 71

10. Be willing to follow the procedures described in the next sections 72

73

There are some conditions that may prevent you from being part of the study. Your study doctor 74

will check if you have these or not. Pregnant or breastfeeding women cannot participate. If you 75

are a woman who has the potential to get pregnant we will do a urine test to be sure you are not 76

pregnant before you enter the study. 77

78

WHAT HAPPENS IF I AGREE TO TAKE PART IN THIS STUDY? 79 This study will take about 14 months for you to complete. This will include up to10 clinic visits 80

and up to 10 telephone/email contacts. 81

82

Screening Visit 83 If you decide to take part in the study, you will sign this consent form. Then we will ask you 84

some questions and you will have some blood tests done. These questions and blood tests will 85

make sure you are eligible and it is safe for you to be in the study. 86

87

These include the following: 88

Collection of information about your diabetes history and management, your medical 89

conditions and medications, and menstrual history (females). 90

Physical exam 91

Blood tests for HbA1c, thyroid levels, liver function, blood counts, celiac disease 92

screening, and blood insulin levels. 93

A urine pregnancy test (if you are a female who can become pregnant) 94

95

You will be asked to complete questionnaires that ask about your and your family’s quality of 96

life, your diabetes management, and how you feel about your current treatment for diabetes. 97

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98

A CGM sensor will be placed. This CGM will record your glucose levels for up to 2 weeks, but 99

you will not be able to see them. This is called blinded CGM. You will be taught how to care 100

for the CGM. The blinded CGM will require little action from you. You will be asked to do at 101

least 4 fingerstick blood glucose checks daily with your own blood glucose meter. This is part of 102

good diabetes management. 103

104

Treatment Group Determination and Initial Training 105 You will come back to the clinic 2 weeks after screening. During this visit your use of the CGM 106

will be checked, and your bloodwork results from screening will be reviewed. Your pump 107

settings may be changed based on the CGM information. If you were not able to use the blinded 108

CGM enough during the 2 weeks, you will be asked to repeat the 2 weeks. We will also recheck 109

your HbA1c if it has been more than 4 weeks since screening. A urine pregnancy test will be 110

done iif you are a female who can become pregnant. 111

112

At this visit, a computer program will be used to select whether or not you will be given the 113

study system or continue to use your own insulin pump. This is similar to flipping a coin. There 114

is a 50/50 chance you will be in either group. Neither you nor your study team will have a 115

choice in which group you will be placed. 116

117

Both groups will receive diabetes education. The education will cover key parts of diabetes 118

management. 119

120

You will be given a blood glucose meter, a blood ketone meter, and test strips. You should check 121

your glucose at least 4 times every day. We will give you instructions on when to use the 122

ketone meter. 123

124

If you are in the group using the study system, you will be switched from your usual insulin 125

pump to the study pump. This could be done on the same day or within the next few weeks. You 126

will be taught how to use the new pump. You will need to bring your own insulin to this visit. 127

On either the same day as switching to the study pump or at another visit within a week of 128

starting to use the study pump, you will start using the study CGM and be taught how to use it. 129

You will use the study pump and study CGM until you return for another visit in about 4 weeks. 130

During this visit, you will receive more training on the at-home study procedures. 131

132

133

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At-Home Procedures 134

Pump Only Group 135 You should continue to check glucose levels with the study glucose meter at least 4 times every 136

day. You will use the ketone meter to check for ketones if your fasting glucose is 250mg/dl or 137

higher and at other times according to instructions we give you. You will be given a phone 138

number to call study staff if you are having any problems. 139

140

Study System Group 141 At the 4-week visit, you will receive training on how to use the study system and will be given 142

written instructions. When you leave the clinic, you will be using the study system. You should 143

check glucose levels with the study blood glucose meter at least 4 times each day. Two of these 144

checks should be before breakfast and before your evening meal. When you check at these 145

times and see that your fingerstick glucose is higher than your sensor glucose by 50mg/dL or 146

more, you will need to enter your fingerstick glucose level into the pump. This will calibrate 147

(readjust) the system. The study pump also may alert you for calibration glucose checks in 148

addition to the usual times you check. You will enter all calibrations into the pump. 149

150

You will use the ketone meter to check for ketones if your fasting glucose is 250mg/dl or higher. 151

Your study team may also give you other times to check your ketones. 152

You will use the Bolus Wizard calculator for all your meal bolus doses. 153

154

If you become sick during the study, you will be taught to switch out of the closed-loop function 155

and follow your study team’s sick day guidelines. 156

157

You will be uploading the study system to a secure website at least once every week. This 158

process takes 5-15 minutes to complete. 159

160

During the first 2 weeks of using the closed-loop system we ask that you do not travel outside the 161

United States. 162

Telephone/email contacts 163

You will be contacted by email or telephone 24-48 hours after starting the study treatment. You 164

will be contacted again in one week, and again in two weeks. After that, you will be contacted 165

every month in between the follow up clinic visits. 166

167

The reason for these contacts is to troubleshoot any problems, and to ask you about any changes 168

in your insulin settings and your health. 169

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Follow-up visits 170

You will return to the clinic for visits after 1 week and then after 3, 6, and 9 months. At each study 171

visit, we will review your diabetes management and may recommend changes. Data will be 172

uploaded from the study devices. 173

174

Follow-up visits at 3, 6, and 9 months also will include the following activities: 175

Finger stick to measure blood glucose level 176

Body weight will be checked 177

Questionnaires will be completed if not done online before the visit. 178

Blood sample will be taken for HbA1c. 179

A urine pregnancy test (if you are a female who can become pregnant) 180

181

At the end of each visit and again after about 12 months, you will use the blinded CGM. This CGM 182

will be worn at home for up to 14 days and then returned to the clinic. If you are in the pump-only 183

group, we will review the CGM data with you. We may have you make changes to your pump 184

basal rates and insulin bolus settings. 185

186

Final Visit 187 The final study visit will be about 14 months after the screening visit. Procedures will be similar 188

to those described for the 3, 6, and 9 month visits. 189

190 You and your family may be asked to join a focus group. In this group you will be asked how you 191

feel about your current insulin delivery device, about being in a research study, and about your 192

quality of life. These focus groups may be audio- and/or video-recorded and then transcribed. 193

194

If you are in the group using the study system, you will return all study devices. You will need to 195

bring your own insulin to this visit. At this visit, you will be switched back to the insulin pump 196

you were using before entering the study. 197

198

If you decide not to take part in this study and do not sign this document, you may continue 199

receiving medical care not related to this study. You can decide to stop your participation in this 200

study at any time. No penalty or loss of medical care will result from your decision not to take 201

part in this study. 202

203

In the table below you will find what will happen at each visit. 204

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Visit(V)/

Contact(C)1 V1 V2 V32 V3a3 V4 C1 V5 C2,3,4 V6 C5, 6 V7 C7, 8 V8 C9,

10 V9 V10

Screening Treatment

start

Medical and

diabetes

history X

Height/

weight X X

Blood

Pressure X X

Draw Blood X X4 X X X X

Urine

Pregnancy

Test X X X X X

Review

medications X X X X X X X X X X X X X X

1 Contact may occur via clinic visit, phone, or email. 2 Could happen on same day as V2. 3 Closed Loop System Group Only. 4 If V3 and V1 are more than 28 days apart.

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Visit(V)/


10 V9 V10

Screening Treatment

start

Review

health

changes

(illness,

injury)

X X X X X X X X X X X X X X

Fingerstick

blood sugar X X X X X

Questionnai

res X X X X X

Blinded

CGM X X X X X X

Upload

device(s) in

clinic X X X X X X


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Visit(V)/


10 V9 V10

Screening Treatment

start

Treatment

Group

Decided X

Pump

Education X X

Study Pump

Start3 X

Study CGM

training and

Start3 X

Start Study

System3 X


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Visit(V)/


10 V9 V10

Screening Treatment

start

Review

blood

sugars,

CGM,

device use

and ketones

X X X X X X X X X X X X X X X

Focus

Group X

Upload

device(s)

from home X X X X X X X X X X X X X

1 Contact may occur via clinic visit, phone, or email. 205 2 Could happen on same day as V2. 206 3 Closed Loop System Group Only. 207 4 If V3 and V1 are more than 28 days apart. 208 209

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ARE THERE RISKS IN THIS STUDY? 210 Taking part in research often involves some risks of physical or psychological injury or discomfort. 211

The most likely risks of this study are described below. These deserve careful thought. We 212

encourage you to discuss the risks with your study team or any other health care professional. 213

214

Risk of Hypoglycemia (Low Blood Sugar) 215 As with any person who uses insulin, there is always a risk of having low blood sugar 216

(hypoglycemia). Symptoms of low blood sugar can include: 217

sweating 218

shaking 219

not feeling well 220

fainting 221

seizures (convulsions) 222

In very rare cases low blood sugar can lead to brain damage or death. Even if low blood sugar does 223

occur, it almost always goes away quickly with treatment to raise the blood sugar. 224

225

Risk of Hyperglycemia (High Blood Sugar) 226 Hyperglycemia usually does not cause many obvious symptoms, but you may be thirsty, or have a 227

higher level of sugar in your urine. In severe cases of hyperglycemia, diabetic ketoacidosis (DKA) 228

or coma may occur. DKA can lead to kidney failure, irregular heartbeat, heart attack, muscle 229

breakdown, and even death. 230

231

Fingerstick Risks 232 It may hurt when the lancet goes into your finger but not for long. In about 1 in 10 cases a small 233

amount of bleeding under the skin will produce a bruise. A small scar may persist for several 234

weeks. The risk of an infection is less than 1 in 1000. 235

236

Blood Drawing Risks 237 Possible risks from blood draws include: 238

Bruising (common) 239

Temporary arm discomfort from the needle stick (common) 240

Clotting (unlikely) 241

Excessive bleeding (unlikely) 242

Lightheadedness (rare) 243

Infection (rare) 244

Fainting (rare) 245

246

Total blood loss during this study is approximately 28 milliliters or about 5-6 teaspoons. 247

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248

Insulin Pump Therapy Risks 249 The risks of using an insulin pump may include: 250

Discomfort during insertion of the infusion set (common) 251

Bruising at the site of infusion set insertion (common) 252

Bleeding at the site of insertion (rare) 253

Infection at the site of insertion (rare) 254

Allergy to the infusion set or adhesive (rare) 255

Insulin pump malfunction and mechanical problems (rare) 256

Allergy to insulin (very rare) 257

Changes to your skin (very rare) 258

259

Continuous Glucose Monitoring (CGM) Sensor Risks 260 Potential risks from using a CGM include: 261

Discomfort when the sensor is inserted into the skin (common) 262

Itchiness, redness, bleeding and bruising at the insertion site (unlikely to rare) 263

Tape allergies (rare) 264

Infection at the site of sensor insertion (rare) 265

266

Study System Risks 267 Even though the study system has been tested extensively prior to this study, there is still a risk that 268

parts of the system may not work right. As a result, you could get less or more insulin than you 269

need and be at risk for hyper- or hypoglycemia. The following are common cases of system 270

malfunction: 271

CGM sensor reads higher or lower than your actual glucose level. 272

CGM sensor stops working or cannot communicate with the system. If this occurs, the 273

pump will start delivering its preset basal rates within 30-60 minutes. 274

275

Risk of Sharing the Continuous Glucose Monitor 276 We may use some of the devices with other study participants. The sensors will not be shared. 277

The transmitter, which snaps into the sensor, will be cleaned carefully after use. The FDA 278

approved the continuous glucose transmitter as a “single use device.” This means that they 279

recommend that only one person use this device as there is a rare risk that a blood-borne 280

pathogen, such as Hepatitis B, may be spread if used with multiple patients. 281

282

283

Risk of Sharing the Insulin Pump 284

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The FDA approved the insulin pump for “single-patient use.” They suggest that only one person 285

use this device as there is a rare risk that a blood-borne pathogen, such as Hepatitis B, may be 286

spread if used with multiple patients. The insulin pump may be reused after it has been cleaned 287

thoroughly with the appropriate cleaning solution after use. 288

289

Questionnaires and Focus Groups 290 The questions asked on the questionnaires and during the focus groups will include questions about 291

your personal attitudes, feelings, and behaviors related to diabetes. It is possible you may find these 292

questions to be upsetting. If any questions make you uncomfortable, you can refuse to answer. 293

take a break, or stop taking part in the study at any time. There are no physical risks present. 294

Many precautions will be made to keep your information confidential, but this is not a guarantee. 295

Similar questionnaires and interviews have been used in other studies and this reaction is 296

uncommon, but you are not required any questions which make you uncomfortable. 297

Unknown Risks 298 There may be additional risks associated with the study system that are not known at this time. 299

If we become aware of any new risks, you will be told about them. You will be able to decide if 300

you want to continue to take part in this study. 301

302

Loss of Privacy 303 We will be collecting your initials and date of birth. The study team will do its best to make sure 304

that your private information is kept confidential. Information about you will be handled as 305

confidentially as possible, but participating in research may involve a loss of privacy and the 306

potential for a breach in confidentiality. All identifiable information about you will be replaced 307

with a code. A list linking the code and your identifiable information will be kept separate from 308

the research data. 309

310

Information about your data uploaded from your study devices will be collected for the study and 311

transmitted through a secure electronic system to the Jaeb Center for Health Research in Tampa, 312

Florida. This center is coordinating the study. It reviews all of the study information that is 313

collected. The Jaeb Center for Health Research will be reviewing the data, but will not have 314

your personal information. 315

316

There is a team at Stanford University in Stanford, California, who will have your personal email 317

address. It will be used to contact you with reminders to complete the online questionnaires. 318

They will not use your email address for any other purpose. Your email address will not be sold, 319

shared, or given to any third parties. 320

321

WHAT ARE THE BENEFITS OF TAKING PART IN THIS STUDY? 322

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There may be a possible medical benefit to you if you decide to take part in the study, but it is 323

not a guarantee. For instance, it is possible that your blood sugar control will improve during the 324

study using the study system or using just your insulin pump. If you are just using the insulin 325

pump, the blood sugar information from the CGM along with the instructions given for 326

management changes will be useful for your diabetes control. 327

328

You may receive no direct benefit from being in the study. People who take part in this research 329

study will add new knowledge that may help other people with type 1 diabetes. 330

331

WHAT ALTERNATIVE PROCEDURES OR TREATMENT ARE AVAILABLE IF I DO 332

NOT TAKE PART IN THIS STUDY? 333 If you do not take part in this study, you could continue using your current insulin pump. You 334

could also talk with your doctor about other ways to take insulin. If you do not participate, your 335

medical care will not be affected. 336

337

We encourage you to discuss these options with your study team, your general primary care 338

physician, or another health care professional who has knowledge of type1 diabetes. 339

340

WHAT IF I WANT TO WITHDRAW FROM THE STUDY, OR I AM ASKED TO 341

WITHDRAW FROM THE STUDY? 342

343 You can stop participating in this study at any time. You may continue to receive medical care 344

not related to this study. However, we encourage you to talk to a member of the study team so 345

they know why you are stopping the study. 346

347

If you withdraw from the study, the study team would like to collect a blood sample for HbA1c 348

13 months after your study treatment determination visit. 349

350

If there are any new findings during the study that may affect your participation, you will be told 351

about them so you can decide if you want to continue. 352

353

No penalty or loss of medical care will result from your decision. You may continue to receive 354

medical care not related to this study. 355

356

The investigators, physicians or funding source may stop the study or take you out of the study at 357

any time. They may remove you from the study for various administrative and/or medical 358

reasons. They can do this without your consent. 359

Some reasons why you may be removed from include: 360

The doctors judge that it is in your best interest 361

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The doctors think that being in the study may cause you harm, especially if you have a 362

severe low blood sugar or DKA 363

If you experience a study-related injury 364

If you need additional or different medication 365

If you do not follow the study plan. 366

367

If you are removed from the study or the study is stopped, you may continue to receive medical 368

care not related to this study. 369

370

ARE THERE COSTS RELATED TO TAKING PART IN THE STUDY? 371 Testing that is specifically for this study will be paid for by the study. The costs of treatment, 372

office visits, and tests that are part of your type 1 diabetes will be your or your insurance 373

company’s responsibility. The study will pay for: 374

CGM-pump System, system supplies, and smartphone (Study System Group) 375

Blood Glucose Meter, Test Strips, and Control Solution (Both groups) 376

Blood Ketone Meter, Test Strips, and Control Solution (Both groups) 377

Blinded CGM (Both groups) 378

379

At the end of the study, or if you decide to remove yourself from the study, you must return the 380

study system and the blinded CGM to the study team listed on the Cover Page. 381

382

All other tests and procedures, including your own insulin, the screening bloodwork, and other 383

medical problems that would happen even if you were not in this study are your or your 384

insurance company’s responsibility. 385

386

IS THERE COMPENSATION FOR TAKING PART IN THIS STUDY? 387 If you take part in the study, you will be paid as described below for each completed visit 388

required for the study to cover travel and other visit-related expenses at the completion of the 389

study. 390

• Visit 1 and 2: $100 for visit/$25 for baseline survey completion for total of $125 391

• Visit 3: $100 (training visit) 392

• Visit 4: $25 (treatment initiation and blinded CGM insertion) 393

• Visit 5: $25 (follow-up 1-week following treatment initiation) 394

• Visit 6: $100 for visit/ $25 if questionnaires completed during visit/$50 if 395

questionnaires completed at home for maximum total of $150 396





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• Visit 9: $25 (blinded CGM insertion) 401

• Final visit: $100 for visit/ $25 if questionnaires completed during visit/$50 if 402


404

If you remove yourself from the study, you will be paid for the number of visits you have 405

completed. Additional expenses will be paid in select cases for participants with higher travel 406

expenses. 407

408

You will not receive any additional compensation for extra visits your doctor believes are needed 409

for your usual care 410

411

WHAT HAPPENS IF I EXPERIENCE A RESEARCH RELATED INJURY? 412 Medical care is available if you have a research-related injury. If you have an emergency, you 413

can get emergency care. If possible, you should tell the emergency care medical staff that you are 414

in a research study. You should also tell your study team about the emergency as soon as 415

possible. 416

417

The study will not provide costs for medical expenses or any other costs for research-related 418

injuries. The costs of care are your or your insurance company’s responsibility. Money for lost 419

wages and/or direct or indirect losses is not available. 420

421

CONTACT INFORMATION FOR QUESTIONS OR PROBLEMS 422 If you have questions about this study, a research-related injury, have concerns, suggestions, or 423

questions about the study, contact your study team using the provided contact information on the 424

Cover Page. 425

426

If you have unanswered questions about your rights as a research participant, wish to talk about 427

your concerns or suggestions linked to the research study, want additional information about the 428

research, or want to provide comments about the research, contact the Jaeb Center for Health 429

Research Institutional Review (IRB) Office at 813-975-8690 or [email protected] 430

431

HOW WILL MY INFORMATION BE PROTECTED AND KEPT CONFIDENTIAL? 432 As required by law, study related records with identifying information will be kept confidential. 433

Safeguards for authorized access, security, and privacy of your information have been put in 434

place by the Federal Privacy Regulations. Unless the law requires it, your name, address, social 435

security number, telephone number, or any other direct identifying information will not be used 436

to identify you. 437

438

A. Purpose of Authorization 439

mailto:[email protected]

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We have rules to protect information about you. Federal and state laws and the federal medical 440

Privacy Rule also protect your information. By signing this form you provide your permission, 441

called your “authorization,” for the use and disclosure of information protected by the Privacy 442

Rule. 443

444

You must sign the Protected Health Information Authorization at the end of this form if you 445

want to be in the study. When you sign the form, you give permission for the use and disclosure 446

of your Protected Health Information (PHI) for the study. PHI is health information that 447

identifies you. Your authorization is beneficial and important for the study. Without your 448

authorization, you will not be able to be in this research study. 449

450

B. Use and Disclosure of the PHI 451 Your study doctor will collect information about you. This information includes things learned 452

from procedures listed and described in this form as well as your name, address, date of birth, 453

and information from your medical records. Your name, address, telephone number, and social 454

security number are examples of identifiable information. 455

456

A code number will replace your name, address, telephone number, or social security number in 457

the results given to the study coordinating center which is the Jaeb Center for Health Research in 458

Tampa, Florida. 459

460

The study doctor’s office will not disclose study results that have your identifiable information 461

except as explained in Section C. or when required by law. The Jaeb Center and this doctor’s 462

office will guard the privacy of your study PHI. 463

464

Study results without the protected information may be shared in medical journals and at 465

scientific meetings. Your records will be confidential. No one will disclose your identity in a 466

medical journal or at a scientific meeting. 467

468

C. Authorized Recipients and Users 469 It is possible that people outside of this doctor’s office and the Jaeb Center may need to see or 470

receive your information from this study. Some examples include: government agencies (such as 471

the Food and Drug Administration), committees that monitor safety, other sites in the study, and 472

companies that sponsor the study. 473

474

In most cases the information will have a code number with it instead of your name, address, 475

telephone number, or social security number. 476

477

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There are some situations where the information will not have a code number but may include 478

your name, address, telephone number, or social security number (PHI). If so, people outside this 479

doctor’s office who assist in your care may see your study PHI. They may not be covered by the 480

federal Privacy Rule. Everyone who needs to see your information will be told it is confidential 481

– but we cannot guarantee fully confidentiality. 482

483

Other Considerations 484 The data collected in the study may be provided to other researchers to use; however, the data 485

that are provided will not contain any information that could identify you. 486

487

When the results are made public, all of the study data collected may also be made public. 488

However, there will be no identifying information included. 489

490

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 491

by U.S. Law. This Web site will not include information that can identify you. At most, the 492

Web site will include a summary of the results. You can search this Web site at any time. 493

494

D. Cancellation of HIPAA Authorization 495 You may cancel your permission for the use and disclosure of your study PHI at any time. You 496

need to contact your study doctor and give him/her a notice of cancellation in writing. When you 497

cancel your permission or when you withdraw from the study directly, you are no longer part of 498

the study. No new information about you will be gathered for the study except when there is an 499

adverse (unfavorable) event that is related or potentially related to the study. If an adverse event 500

happens, your entire medical record may need to be reviewed. 501

502

The Jaeb Center will receive all the information that was collected for the study up to the time of 503

cancellation or withdrawal. The Jaeb Center will receive any new information about any adverse 504

(unfavorable) event that is related or potentially related to the study. 505

506

507

508

509

E. 50 Year Expiration Date and Indefinite Expiration Date 510 Some of your study PHI does not have a code number with it. Your permission for the use and 511

disclosure of this PHI lasts 50 years from the date of your signature or until the end of the study, 512

whichever is sooner. 513

514

http://www.clinicaltrials.gov/

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The rest of your study PHI does have a code number with it. When it is collected, it becomes a 515

research report. Your permission for the use and disclosure of these coded data will never end. 516

These coded data do not have your name, address, telephone number, or social security number. 517

The above supports the HIPAA Privacy Rule – 45 CFR 164.508 518

519

520

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STANFORD UNIVERSITY LOCAL REQUIRED LANGUAGE 521 522 Research –related Injury 523 524

This portion is complementary to the section WHAT HAPPENS IF I EXPERIENCE A 525

RESEARCH RELATED INJURY? 526

527

All forms of medical diagnosis and treatment – whether routine or experimental – involve some 528

risk of injury. In spite of all precautions, you might develop medical complications from 529

participating in this study. If such complications arise, the Protocol Director and the research 530

study staff will assist you in obtaining appropriate medical treatment. In the event that you have 531

an injury or illness that is directly caused by your participation in this study, reimbursement for 532

all related costs of care first will be sought from your insurer, managed care plan, or other 533

benefits program. You will be responsible for any associated co-payments or deductibles as 534

required by your insurance. 535 536

If costs of care related to such an injury are not covered by your insurer, managed care plan or 537

other benefits program, you may be responsible for these costs. If you are unable to pay for such 538

costs, the Protocol Director will assist you in applying for supplemental benefits and explain how 539

to apply for patient financial assistance from the hospital. 540 541 CA Bill of Rights 542 543 As a research participant, you have the following rights. These rights include but are not limited 544

to the participant's right to: 545

• be informed of the nature and purpose of the experiment; 546

• be given an explanation of the procedures to be followed in the medical experiment, and any 547

drug or device to be utilized; 548

• be given a description of any attendant discomforts and risks reasonably to be expected; 549

• be given an explanation of any benefits to the subject reasonably to be expected, if applicable; 550

• be given a disclosure of any appropriate alternatives, drugs or devices that might be 551

advantageous to the subject, their relative risks and benefits; 552

• be informed of the avenues of medical treatment, if any available to the subject after the 553

experiment if complications should arise; 554

• be given an opportunity to ask questions concerning the experiment or the procedures 555

involved; 556

• be instructed that consent to participate in the medical experiment may be withdrawn at any 557

time and the subject may discontinue participation without prejudice; 558

• be given a copy of the signed and dated consent form; and 559

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• be given the opportunity to decide to consent or not to consent to a medical experiment 560

without the intervention of any element of force, fraud, deceit, duress, coercion or undue 561

influence on the subject's decision. 562

563 Stanford University HIPAA Authorization 564 565 In order to participate in this study, you must also sign the Stanford University HIPAA Authorization 566 Form. 567 568 569 570 571 572 573 574 575 576 577 578 579 580 581 582 583 584 585 586 587 588 589 590 591 592

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Your Full Name (printed) 593

594

Description of Representative’s Authority to Act for the Subject 595 ________________________________________________ (if applicable) 596

597

Protected Health Information Authorization 598

599

600

Study Enrollment 601

602

You will be given a signed copy of this document in case you want to read it again. 603

604

By signing, you authorize the use and disclosure of your protected health information. This

information is collected as part of your participation in this study.

Signature Date

By signing, you agree to take part in this study. Your signature means that:

you have read this informed consent form about the study named below;

you have been given the chance to discuss the study and to ask questions;

you have verbally summarized your understanding of the study to the person who is

explaining it to you; and

you freely choose to participate.

Name of Study: Day and night closed-loop in young people with type 1 diabetes (DAN05)

Signature Date

I certify that to the best of my knowledge the participant understands the nature, demands,

risks, and benefits involved in his/her participation in this study.

_______________________ _______________________ ___________

Investigator’s Printed Name Investigator’s Signature Date

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